Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000737831
Ethics application status
Approved
Date submitted
25/05/2012
Date registered
10/07/2012
Date last updated
30/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The pain relief after key hole surgery for gall bladder : Is infiltration of wound with Local anaesthetics is better than the injecting in to the abdominal wall.
Scientific title
Comparison of Local Anaesthetic wound Infiltration and Transversus Abdominis Plane (TAP) Block for pain releif in Laparoscopic Cholecystectomy surgery - A Retrospective Study
Secondary ID [1] 280516 0
NIL
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic cholecystectomy 286505 0
pain management studied 286568 0
Condition category
Condition code
Anaesthesiology 286766 286766 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Not applicable - Observational study: in this study no experimental intervention or treatment is applied.It involves observations done in the retrospective manner.Data obtained from hospital database from yr Dec-2011-June-2012 Acute pain service data also used.Since the surgery has already been done there is no intervention in that course. But the satisfaction outcomes are measured by doing a likert score to observe what extent these methods benefited in each group.
Intervention code [1] 284892 0
Not applicable
Comparator / control treatment
There are only two groups
Active group: Wound infiltration group ( Bupivacaine)
The comparator group: The transversus abdominis plane (TAP) (Mode of administration of bupivacaine in TAP plane.)
Control group
Active

Outcomes
Primary outcome [1] 287152 0
The primary out come:1. compare the immediate postoperative pain score at 0hr 1hr in recovery room

pain scores assesed on numerical rating scale of 0-10
Timepoint [1] 287152 0
pain scores and Discharge Time in recovery and ward

Pain scores assesed on numerical rating scale of 0-10
Time in minutes
Primary outcome [2] 287197 0
2.Amount of analgesics used in the immediate postoperative period in Recovery room and Ward. Out come will be assessed by using the Acute pain service data for pain scores and also from the inpatient medical records.
Timepoint [2] 287197 0
0 hr 1hr in recovery room and in ward
Secondary outcome [1] 297507 0
Quality of pain relief assesed on Likert scale for satisfaction : 4 point rating used: 1. completely relieved; 2. relieved; 3. somewhat relieved; and 4. not relieved.
Timepoint [1] 297507 0
single time point 30-180 days post discharge

Eligibility
Key inclusion criteria
Only patients who had laparoscopic cholecystectomy
Only patient with Laporoscopic cholecystectomy who had Bupivacaine 0.25% local anesthetic
Only patient with Laporoscopic cholecystectomy who had TAP block with Bupivacaine 0.25% local anesthetic
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had not received Local anaesthetics as above And patient who had not recived TAP block methods. Patients with insufficient data
patient who were not able to interview for satisfaction score

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Group differences on continuous variables were assessed using the Wilcoxon (Mann-Whitney) test. Differences on dichotomous measures were assessed using Pearson’s Chi-square statistic or Fisher’s Exact test as appropriate. All tests were two-tailed and statistical significance was assessed at a 5% alpha level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2012
Actual
29/05/2012
Date of last participant enrolment
Anticipated
29/07/2013
Actual
29/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 2525 0
The Queen Elizabeth Hospital - Woodville

Funding & Sponsors
Funding source category [1] 285280 0
Self funded/Unfunded
Name [1] 285280 0
NIL
Country [1] 285280 0
Primary sponsor type
Individual
Name
vasanth Rao
Address
28 Woodville rd
Woodville
SA 5011
Country
Australia
Secondary sponsor category [1] 284140 0
None
Name [1] 284140 0
Address [1] 284140 0
Country [1] 284140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287295 0
HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH)
Ethics committee address [1] 287295 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 287295 0
Australia
Date submitted for ethics approval [1] 287295 0
Approval date [1] 287295 0
18/04/2012
Ethics approval number [1] 287295 0
2011148

Summary
Brief summary
The key hole gall bladder surgery is one of the commonest surgery performed. there are various methods used for pain relief after the surgery.Traditionally local anaesthetics is injected into the wounds.Recently by ultrsound guidance local anaesthetics were injected into the abdonminal planes (transverses abdominis plane).The nerves supply the the entire abdominal wall. Recent trials did show they benefit in abdominal surgery. So far only one trial compared these two methods.The purpose of this trial is to find out which one of them did better in regards to pain releief. Also patient satisfaction score may reveal which of these methods were acceptable
Trial website
not available
Trial related presentations / publications
Comparison of Ultra sound guided Bilateral subcostal Transversus abdominis plane block vs Local Anaesthetic infiltration technique for laparoscopic cholecystectomy- Retrospective study
V.Rao Kadam*, S.Howell, V.Kadam
15/04/2014. E-Poster presented at the AUstralian pain society meeting Hobart.
The citatation is only in the conference proceedings but not in the Journal yet
Public notes

Contacts
Principal investigator
Name 34199 0
Dr vasanth rao kadam
Address 34199 0
The Queen Elizabeth Hospital 28 Woodville Road Woodville South SA 5011
Country 34199 0
Australia
Phone 34199 0
+610882226640
Fax 34199 0
Email 34199 0
[email protected]
Contact person for public queries
Name 17446 0
Dr Vasanth rao
Address 17446 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 17446 0
Australia
Phone 17446 0
+61 08 8222 6440
Fax 17446 0
+61 08 8222 7065
Email 17446 0
[email protected]
Contact person for scientific queries
Name 8374 0
Dr Vasanth rao
Address 8374 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 8374 0
Australia
Phone 8374 0
+61 08 8222 6440
Fax 8374 0
+61 08 8222 7065
Email 8374 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of postoperative pain scores following ultrasound guided transversus abdominis plane block versus local infiltration following day surgery laparoscopic cholecystectomy-retrospective study.2016https://dx.doi.org/10.4103/0970-9185.168195
N.B. These documents automatically identified may not have been verified by the study sponsor.